Ongoing Clinical Trials Actively Recruiting Children With Cancer

The information in this Clinical Trials Resource Guide includes actively recruiting clinical studies of children with cancer. The studies include pilot and phase I and II studies evaluating new therapies, functional imaging tests, tests to measure the neuropsychological and behavioral function in young patients with cancer, and interventions to improve cognitive late effects from treatment. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.

Trials for Children With Cancer

Study Type: Phase I/II/interventional/nonrandomized

Study Title: Phase I and Phase II Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma

Study Sponsor and Collaborators: National Cancer Institute

Purpose: AZD6244, an experimental drug designed to prevent tumor growth and shrink existing tumors, has been studied in adults with cancer, but has not been studied in children with cancer. Researchers want to see if AZD6244 is a safe and effective treatment for older children and young adults who have gliomas that have not responded to standard treatments.

Ages Eligible for Study: 3 to 21 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: To estimate the maximum tolerated dose or recommend a phase II dose; to describe the toxicity profile and define the dose-limiting toxicity of AZD6244 in children with recurrent or refractory low-grade gliomas

Principal Investigator: Katherine E. Warren, MD, National Cancer Institute, 301-435-4683, warrenk@mail.nih.gov

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01386450

Study Title: Phase I Study of Single Agent Perifosine for Recurrent Pediatric Solid Tumors

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center

Purpose: To test whether perifosine—a drug that inhibits the protein AKT and has had some success in the treatment of adult cancers—is safe and effective in treating cancer. Investigators want to find out what effects the agent has on patients and the cancer. Different dosing schedules of perifosine are planned.

Ages Eligible for Study: Up to 21 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Maximum tolerated dose of perifosine monotherapy in children with cancer (time frame: conclusion of the study)

Principal Investigator: Ira Dunkel, MD, Memorial Sloan Kettering Cancer Center, 212-639-2153

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00776867

Study Title: Development of Radiation Free Whole Body MR Imaging Technique for Staging of Children With Cancer

Study Sponsor and Collaborators: Stanford University

Purpose: To compare the sensitivity of whole-body magnetic resonance imaging (MRI) and ¹⁸F-fluorodeoxyglucose positron-emission tomography (FDG-PET) for detecting metastatic disease in children with malignant lymphomas and malignant sarcomas

Ages Eligible for Study: Up to 40 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Comparison of sensitivity, specificity, and accuracy of whole-body diffusion-weighted MRI scans to ¹⁸F-FDG-PET scans (time frame: the outcome will be measured after image acquisition)

Principal Investigator: Heike Daldrup-Link, MD, Stanford University; contact: Christopher Klenk, 650-798-9096, cklenk@stanford.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01542879

Study Title: A Randomized Controlled Trial Evaluating an Enhanced Physical Activity Intervention to Improve Cognitive Late Effects in Children Treated With Cranial Radiation for Brain Tumors

Study Sponsor and Collaborators: National Cancer Institute

Purpose: Late effects from cancer treatment in children can cause difficulties in cognitive functions, such as attention and memory. Physical activity has been found to improve the attention and memory skills of children with attention deficit hyperactivity disorder. Researchers want to see if physical activity can improve cognitive functions in children who had radiation therapy for a brain tumor.

Ages Eligible for Study: 8 to 17 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Efficacy of 12 weeks physical activity on visual memory (time frame: 12 weeks)

Principal Investigator: Pamela L. Wolters, PhD, National Cancer Institute, 301-496-0561, woltersp@mail.nih.gov

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02153957

Study Title: Pilot Study: Functional Imaging of Cerebellar Mutism Syndrome

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center, New York Presbyterian Hospital, Columbia University, and Weill Medical College of Cornell University

Purpose: To better understand why some children with cancer have difficulty speaking after brain surgery. Difficulty speaking may be due to known complications to the language centers in the brain. These language centers may be located in slightly different places in different people. This study will examine which areas may be damaged.

Ages Eligible for Study: 3 to 21 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: To investigate the feasibility of performing preoperative functional MRI (time frame: 1 year)

Principal Investigator: Robert J. Young, MD, Memorial Sloan Kettering Cancer Center, 212-639-8196

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01733173

Study Title: Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer

Study Sponsor and Collaborators: Stanford University

Purpose: To assess the cognitive outcome in childhood cancer as well as evaluate a cognitive rehabilitation program for improving learning and problem-solving difficulties in children with cancer.

Ages Eligible for Study: 9 to 16 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Performance on neuropsychological testing and brain activation patterns measured by functional MRI (time frame: 8 weeks)

Principal Investigator: Shelli Kesler, PhD, Stanford University, 650-723-0058, skesler@stanford.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00490334

Study Title: Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer

Study Sponsor and Collaborators: Children’s Oncology Group, National Cancer Institute

Purpose: To study neuropsychological and behavioral testing in young patients with cancer. Collecting information over time from a series of tests may help doctors develop effective tests to measure neuropsychological and behavioral function in young patients with cancer.

Ages Eligible for Study: 1 month to 21 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Consistent, streamlined, and efficient administration of neuropsychological and behavioral tests (time frame: baseline)

Principal Investigator: Leanne Embry, PhD, Children’s Oncology Group, 210-567-7477, embryl@uthscsa.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00772200

Study Type: Observational/Behavioral: Interview

Study Title: A Qualitative Case Study of the Experiences of Children With Cancer as They Learn About Their Diagnosis and Treatment

Study Sponsor and Collaborators: St. Jude Children’s Research Hospital

Purpose: Little is known about how children with cancer experience learning about their diagnosis and treatment in the hospital setting, or the individuals and materials that may help to facilitate children’s understanding of their diagnosis. This observational study will collect data about how children currently learn about their cancer diagnosis and treatment in the hospital setting to improve how future patients learn about their cancer-related diagnosis.

Ages Eligible for Study: 7 to 11 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Case study of the ways in which children with cancer learn about their diagnosis and treatment in the hospital setting (time frame: observations collected from diagnosis through 6 months)

Principal Investigator: Jessika Boles, MEd, St. Jude Children’s Research Hospital, 866-278-5833, info@stjude.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02041689 ■